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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Remarks:
testing lab.

Test material

Constituent 1
Chemical structure
Reference substance name:
4,5-dihydroxy-1,3-dimethylimidazolidin-2-one
EC Number:
223-496-2
EC Name:
4,5-dihydroxy-1,3-dimethylimidazolidin-2-one
Cas Number:
3923-79-3
Molecular formula:
C5H10N2O3
IUPAC Name:
4,5-dihydroxy-1,3-dimethylimidazolidin-2-one
Details on test material:
Name of the test substance used in the study report: Fixapret NF

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Young adult animals were used. They were identified via ear tattooing. The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20-24°C for temperature and of 30 - 70% for relative humidity. The day/night rhythm was 12 h dark and 12 h light. The animals were housed singly in stainless steel wire mesh carges with grating (floor area: 3000 cm2) with no bedding in the cages (sawdust in the waste trays). A standard diet was used (about 130 g per animal/day) and about 250 ml tap water per animal and per day were available.
Weight of male animals: 3.42 and 366 kg
Weight of the female animal: 3.31 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Both eyes of the animals were examined before application of the test material for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used in the study
Acclimatization period for at least 1 week. Weight determination shortly before application of the test substance.
Single application to the conjunctival sac of the right eyelid; the substance was not washed out.
Readings: 1 h, 24 h, 48 h and 72 h after application.
A check was made twice each workday and once on Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Conclusions:
Under the test conditions chosen and considering the described findings, the test substance does not given indication of an irritant property to the eye.